This is a 16-week, prospective, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate psoriasis treated with ANM. Psoriasis severity and stress levels will be measured at Weeks 0, 2, 8, 12, and 16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
Site 1
Fremont, California, United States
BSA x sPGA average percent change from Baseline
Body Surface Area x Static Physician Global Assessment
Time frame: Week 16
sPGA change from Baseline
Static Physician Global Assessment
Time frame: Week 16
BSA change from Baseline
Body Surface Area
Time frame: Week 16
Mean PASI change from Baseline
Psoriasis Area and Severity Index
Time frame: Week 16
PASI 50
Psoriasis Area and Severity Index - 50% reduction
Time frame: Week 16
PASI 75
Psoriasis Area and Severity Index - 75% reduction
Time frame: Week 16
PSSI change from Baseline
Psoriasis Scalp Severity Index
Time frame: Week 16
QVAS change from Baseline
Stress Level Quantified Visual Analogue Scale
Time frame: Week 16
DLQI change from Baseline
Dermatology Life Quality Index
Time frame: Week 16
PQOL-12 change from Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Psoriasis Quality of Life - 12 Item
Time frame: Week 16
HADS change from Baseline
Hospital Anxiety and Depression Scale
Time frame: Week 16
Pruritus NRS change from Baseline
Pruritus Numerical Rating Scale
Time frame: Week 16
Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement)
Pruritus Numerical Rating Scale
Time frame: Week 16
TSQM
Treatment Satisfaction Questionnaire for Medication
Time frame: Week 16